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BH-5390 5-Part-Diff Auto Hematology Analyzer
EUDAMEDClass B (EU MDR)
Ref /Model URIT-5160、BH-5100 、BH-5390
Identity
- Trade Name
- BH-5390 5-Part-Diff Auto Hematology Analyzer EUDAMED
- Device Name
- 5-Part-Diff Auto Hematology Analyzer EUDAMED
- Model / Reference
- URIT-5160、BH-5100 、BH-5390 EUDAMED/ EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06935740725316 EUDAMED
- Basic UDI-DI
- 69357407IBH000002N9 EUDAMED
- Direct Marketing DI
- 06935740725316 EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
BH-5390 5-Part-Diff Auto Hematology Analyzer by URIT Medical Electronic Co., Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 69357407IBH000002N9 | Class B | Active |
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Manufacturer
- Manufacturer
- URIT Medical Electronic Co., Ltd.
- EUDAMED SRN
- CN-MF-000011840
- Authorised Representative
- Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001
Sources (1)
- EUDAMED 7ff20a70-c4a6-45af-8d0f-c3a689962509 61 fields · synced Oct 6, 2026